NCT06112093 · State University of New York - Upstate Medical University
Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches
What this study is about
This study aims to examine the long-term effect of repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation technique, on chronic headaches following mild traumatic brain injury (mTBI). rTMS has been shown to be effective in reducing chronic headaches without side effects commonly seen in medications, such as sleepiness and addiction.
View original scientific description
This study aims to examine the long-term effect of repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation technique, on chronic headaches following mild traumatic brain injury (mTBI). rTMS has been shown to be effective in reducing chronic headaches without side effects commonly seen in medications, such as sleepiness and addiction. This study uses rTMS to manage chronic headaches to improve post-concussion symptoms and reduce the economic burden due to delayed recovery. This project aims to better identify biomarkers for diagnosis and prognosis and maximize recovery from mTBI.
Interventions
DEVICE
Repetitive Transcranial Magnetic Stimulation
rTMS will be used to regulate the motor cortex to reduce headaches and post-concussion symptoms.
DEVICE
Sham Repetitive Transcranial Magnetic Stimulation
Sham rTMS will be delivered by a sham coil as a comparator to the (active) rTMS. Sham rTMS will not change the brain function of the control group.
Primary outcome measures
Daily headache diary
Time frame: daily documentation throughout the treatment course (4 weeks)
Composite headache score will be calculated as average intensity (NRS) × average frequency (episode/day) × average duration (hours/episode).
Patient-Reported Outcomes Measurement Information System (PROMIS)
Time frame: baseline, immediately post-treatment (completion of rTMS), 1-month follow-up, 3-month follow-up, 6-month follow-up
The PROMIS questionnaires with subsections of 1) pain interference, 2) pain behavior will be used as patient-reported outcomes of pain and sleep. For all subsections, on a scale of 1 to 5, higher numbers indicate worse outcomes.
Protein expression
Time frame: baseline, immediately post-treatment (completion of rTMS)
Peripheral blood will be collected to measure protein expression
Neurophysiological measures by TMS
Time frame: baseline, immediately post-treatment (completion of rTMS)
Neurophysiology will be measured by TMS to indicate changes in brain function.
Headache impact test 6 (HIT-6)
Time frame: baseline, immediately post-treatment (completion of rTMS), 1-month follow-up, 3-month follow-up, 6-month follow-up
The HIT-6 will be used to assess the impact of headaches on one's ability to function in occupational and social lives. On a scale of 36 to 78, higher numbers indicate worse outcomes.
Post-Concussion Symptom Scale (PCSS)
Time frame: baseline, immediately post-treatment (completion of rTMS), 1-month follow-up, 3-month follow-up, 6-month follow-up
The change in global post-concussion symptoms will be measured by the PCSS. On a scale of 1 to 5, higher numbers indicate worse outcomes.
Wrist actigraphy - physical activity level
Time frame: baseline, immediately post-treatment (completion of rTMS)
Kinematic assessments by the wrist actigraphy will be worn to measure physical activity level.
Gene expression
Time frame: baseline, immediately post-treatment (completion of rTMS)
Peripheral blood will be collected to measure mRNA to impute gene expression.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 18 - 55 years old
- mTBI with loss of consciousness for less than 30 min, initial Glasgow Coma Scale between 13 and 15, or post-traumatic amnesia for ≤ 24 hours
- diagnosis of persistent post-traumatic headache according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria
- headache develops within 7 days after head trauma
- headache persists for \>=3 months after head trauma despite receiving standard care
- average persistent headache intensity is \>= 3/10 of the numerical rating scale (NRS) on \>=3days/week
- no evidence of radiculopathy or peripheral neuropathy on electromyography or clinical evaluation
- no evidence of other possible causes of headaches
Exclusion criteria
- history of chronic headache diagnoses such as migraine, tension, or cluster headaches prior to the incidence of mTBI
- history of other neurologic conditions with medications affecting the central nervous system
- contraindications of receiving TMS (e.g., a history of epileptic seizure and having implants like a cardiac pacemaker or intracerebral vascular clip
Where
- Syracuse, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 10, 2025 · Source of record for eligibility and locations